(216 days)
Not Found
Not Found
No
The 510(k) summary describes a physical filter and heat/moisture exchanger for breathing systems, with no mention of software, algorithms, or any terms related to AI/ML.
No.
The device acts as a filter to protect equipment and reduce transmission, and to reduce heat/humidity loss, not to treat a disease or condition in a patient.
No
The provided text describes the device as filters and heat/moisture exchangers designed to prevent transmission of bacteria/viruses and preserve patient heat/humidity. It does not mention any function related to diagnosing diseases or conditions.
No
The device description and intended use clearly describe physical filters and heat and moisture exchangers, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in breathing systems to reduce bacterial/viral transmissions and manage heat and humidity. This is a therapeutic or supportive function related to breathing, not a diagnostic test performed on samples taken from the body.
- Device Description: While the description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Intersurgical Hydro-Guard Mini Filter and Heat and Moisture Exchanger is for use at the patient and equipment connections. It is designed to reduce bacterial/viral transmissions between the patient and equipment and to reduce the loss of patient heat and humidity.
The Intersurgical Air- Guard Breathing Filter is for use at the equipment connections. It is designed to reduce bacterial/viral transmissions in order to protect oxygen concentrator machines and respiratory equipment.
Both filters are single patient use for an adult target patient population, are intended for use within breathing systems in healthcare and home environments where ventilation is required and a maximum duration of 24 hours.
Product codes
CAH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult
Intended User / Care Setting
healthcare and home environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Michael Zalewski Regulatory Affairs/ Quality Assurance Specialist Intersurgical, Incorporated 417 Electronics Parkway Liverpool, New York 13088
MAR 1 0 2010
Re: K092409
Trade/Device Name: 1745 Hydro-Guard Mini Breathing filter and Heat and Moisture Exchanger 1790 Air-Guard Clear Breathing Filter Regulation Number: 21CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: March 1, 2010 Received: March 5, 2010
Dear Mr. Zalewski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2- Mr. Zalewski
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
510(k) Number (if known): K092409
Device Name:
. - --------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1745 Hydro-Guard Mini Breathing Filter and Heat and Moisture Exchanger 1790 Air-Guard Clear Breathing Filter
Indications For Use:
The Intersurgical Hydro-Guard Mini Filter and Heat and Moisture Exchanger is for use at the patient and equipment connections. It is designed to reduce bacterial/viral transmissions between the patient and equipment and to reduce the loss of patient heat and humidity.
The Intersurgical Air- Guard Breathing Filter is for use at the equipment connections. It is designed to reduce bacterial/viral transmissions in order to protect oxygen concentrator machines and respiratory equipment.
Both filters are single patient use for an adult target patient population, are intended for use within breathing systems in healthcare and home environments where ventilation is required and a maximum duration of 24 hours.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
ision of Anesthesiology, General Hospital tion Control, Dental Devices
4092409 J (k) Number: ________________________________________________________________________________________________________________________________________________________________
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Over-The-Counter Use ---------
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